The study will consist of two components. In the first component, OM-MT and EMG-MT will be observed within subjects, with counterbalancing applied to prevent order effects. Pain will be measured by applying a small portion of the FDA-approved 10Hz…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of the study is the difference between the three different
methods in the established cortical threshold within each subject .
Secondary outcome
The secondary endpoint will be the amount of pain perceived within the
FDA-approved protocol for MDD based on either 120% machine output based upon
the EMG-MT or OM-MT.
Background summary
Transcranial Magnetic Stimulation (TMS) is an effective treatment in
depression, especially in stubborn or treatment resistant depression. Since its
discovery in 1985 by Anthony Barker (Barker et al., 1985), TMS was first used
as a treatment for depression by Mark George in 1995 and it has been an
FDA-approved treatment since 2008 (George, 2010). One critical step in the
FDA-approved protocols is determining the resting Motor Threshold (MT) of the
individual patient, allowing the clinician to estimate the minimal
therapeutically effective stimulation strength. Today, three different methods
can be used to establish the MT, each of which can produce a different MT
estimates within the same patient. The three methods are as follows: measuring
the electromyogram (EMG) of the abductor pollicis muscle in the thumb when
applying TMS to the motor cortex responsible for thumb movement (EMG-MT),
observing a muscle twitch in the hand when stimulating the same area (OM-MT)
(Westin et al., 2014), or measuring whether there is a heart rate deceleration
after stimulating the dorsolateral prefrontal cortex (DLPFC)(Dijkstra et al.,
2023).
Study objective
The study will consist of two components. In the first component, OM-MT and
EMG-MT will be observed within subjects, with counterbalancing applied to
prevent order effects. Pain will be measured by applying a small portion of the
FDA-approved 10Hz TMS protocol at 120% of the machine output for both OM-MT and
EMG-MT levels. The perceived pain will then be measured afterward.
In the second component, heart rate deceleration will be used to estimate the
frontal threshold, relative to the OM-MT for each participant.
Study design
A repeated-measures experimental design will be applied, comparing three
different methods of establishing the cortical threshold within each subject.
The order in which these methods are applied will be partly counterbalanced
across subjects. For the secondary objective a the amount of pain or discomfort
during therapeutic stimulation will be compared within one subject between two
conditions (either based upon the OM-MT or EMG-MT).
Study burden and risks
No immediate benefits are to be expected from participation in this study for
the subjects. The total burden of this study will be 90 minutes of time of each
subject for the whole experiment. TMS is considered to be a safe treatment
option with few side effects. The most common side effect is local pain during
stimulation, sometimes followed by headache. TMS is considered a safe and
effective method if safety guidelines and recommendations for applying TMS to
humans are followed (Rossi et al., 2021). If a subject is uncomfortable with
any aspect of the procedure and wants to stop, the session will be terminated
immediately.
Warandelaan 2
Tilburg 5037 AB
NL
Warandelaan 2
Tilburg 5037 AB
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers between 18-55 years old
Exclusion criteria
Exclusion Criteria for Receiving TMS
Participants will be excluded from the study if they meet any of the following
criteria:
1. Neurological and Psychiatric Conditions:
History of epilepsy or seizure disorders,
Previous significant head trauma or traumatic brain injury with loss of
consciousness >5 minutes.
Presence of a known neurological disorder (e.g., stroke, multiple sclerosis,
Parkinson*s disease, brain tumors).
Current or past diagnosis of a severe psychiatric disorder (e.g.,
schizophrenia, bipolar disorder, psychotic disorder).
Current severe depression (e.g., suicidal ideation, recent hospitalization due
to psychiatric reasons).
History of substance use disorder within the past six months.
2. Medical Conditions and Contraindications:
Presence of implanted metal objects or devices in or near the head (e.g.,
cochlear implants, deep brain stimulators, aneurysm clips, electrodes, metallic
fragments).
Pacemaker, defibrillator, or any other implanted electrical medical device.
History of cardiac arrhythmias or other significant cardiovascular conditions.
Uncontrolled hypertension.
History of syncope or unexplained fainting episodes.
3. Medications and Substance Use:
Use of medications known to lower seizure threshold (see list below).
Recent use of recreational drugs or alcohol dependence.
4. Pregnancy and Hormonal Considerations:
Current pregnancy
Hormonal conditions that could influence cortical excitability (e.g., active
hormone replacement therapy).
5. Other Exclusion Factors:
Age below 18 or above 55
History of hypersensitivity or significant discomfort with previous TMS
exposure.
Participation in another clinical trial that may interfere with the results.
Inability to provide informed consent or understand study procedures.
Significant scalp abnormalities, infections, or skin conditions that could
interfere with coil placement.
History of migraine with aura (depending on severity and frequency).
List of medication which exclude from this study:
1. Antipsychotics: • Clozapine • Chlorpromazine • Olanzapine • Haloperidol 2.
Antidepressants: • Tricyclic antidepressants (TCAs): o Amitriptyline o
Imipramine • Selective serotonin reuptake inhibitors (SSRIs): o Fluoxetine o
Paroxetine • Bupropion
3. Mood Stabilizers: • Lithium
4. Stimulants: • Amphetamines (e.g., Adderall, Dexedrine) • Methylphenidate
(e.g., Ritalin, Concerta)
5. Anesthetics and Analgesics: • Tramadol • Meperidine (Demerol)
6. Antibiotics: • Imipenem-cilastatin • Ciprofloxacin • Penicillins
7. Antihistamines: • Promethazine
8. Anti-malarial Drugs: • Chloroquine • Mefloquine
9. Theophylline: • Used for asthma and chronic obstructive pulmonary disease
(COPD).
10. Illicit Substances: • Cocaine • Amphetamines • MDMA (Ecstasy)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88500.028.24 |